Quality Specialist for a versatile role within quality, operations and processes

Motivated by a role where you solve concrete operational tasks, create overview and help ensure quality, processes and systems work in practice? Do you also have attention to detail and enjoy taking responsibility for your areas? Then perhaps you are the one we are looking for.

Amgros’ core task is, in cooperation with hospital pharmacies, to ensure that the necessary medicines are available for patients at the public hospitals. Part of the work includes supporting the production of medicines at hospital pharmacies. Here you work, among other things, to ensure medicines meet regulatory and quality requirements and patient safety requirements.

About the position

As a quality specialist you will have a versatile role that combines responsibility for concrete recurring operational tasks, follow-up on quality data, the department's use of the quality system and collaboration with the quality department.

You will be responsible for carrying out concrete operational tasks, ensuring a stable and precise task execution, and at the same time have an eye for where processes and system support can be improved.

A central part of the role is to be the professional focal point for the department's use of the quality system. Here you will create overview, guide, review and follow up on the department's deviations, change requests, procedures and similar. You do not need to be an expert in all of the department's subject areas, but understand the quality process and help ensure that processes, content and documentation are comprehensive and correct.

You will also act as a link between your own department and the quality department and contribute to ensuring that relevant requirements and quality initiatives are translated into practice.

Your primary tasks will be to

• order, process, verify and upload serial numbers to the EU hub in connection with the production of serialized SAD preparations at the Hospital Pharmacies
• perform SPC control in relation to medicines produced at the Hospital Pharmacies
• ensure well-functioning workflows within the two above areas and contribute to relevant optimization of process and system support
• be the professional focal point for the department's use of the quality system and participate in reviewing deviations, change records, risk assessments, procedures and other quality documentation
• advise and guide colleagues in the use of the quality system and in the requirements for content and documentation in the individual quality cases
• maintain an overview of the department's deviations, change records and procedures and follow up on progress and agreed actions both at regular follow-up meetings in the department and in connection with management review
• collect and follow up on the department's quality data for QMR and contribute to the setting and follow-up of relevant performance indicators
• serve as a link between the department and the quality department, including participating in relevant quality forums and communicating new requirements and initiatives and supporting implementation in the department.

About you

We imagine that you have a relevant educational background and solid experience with quality assurance and quality systems within a GxP-regulated area. You are used to writing and reviewing deviations, change requests, risk assessments and procedures.

You work in a structured and thorough way and thrive with operational tasks that require precision and must be performed correctly and consistently. At the same time you are curious and have an eye for how things can be done better. You have a good process and system understanding, a flair for IT and easily get by new systems and workflows when the task requires it.

You have a sense for data and their interrelations and can translate them into usable overviews and follow-up. At the same time you can see where workflows and system support can be improved. You are familiar with Excel or similar tools and can develop simple and practical solutions that support the work.

You take responsibility for your areas, create an overview and persistently follow up so tasks are driven forward and completed. You do it in a constructive way and are good at collaborating with different people and getting them on board.

You can communicate your knowledge and guide colleagues so quality requirements and processes become understandable and usable in practice, and handled in a consistent way. At the same time you can ask relevant questions and give concrete feedback so, for example, a deviation or change request is sufficiently illuminated and documented.

Finally you have a solution-oriented approach and take action even when the solution is not readily available. You do not need to know the answer in advance, but you have the willingness and perseverance to find it. You thrive with both independent responsibility, recurring operational tasks and close collaboration with others.

Registration, Pharmacovigilance and Quality Support - your new department

You will be part of Registration, Pharmacovigilance and Quality Support, which consists of 17 experienced colleagues with different professional specialisms. Our working environment is informal and open, and we place emphasis on knowledge sharing, professional sparring and helping each other to achieve good results.

Contact and application

We look forward to receiving your application no later than November 12, 2026

If you have questions about the position, you are very welcome to contact department head Christina Fenger at phone 22848885. We look forward to hearing from you.

We encourage all interested to apply for the position – regardless of age, gender, religion, disability and ethnic background.